Quality
Quality, best practise and customer service - there's nothing more important to us. That's why we keep investing in our infrastructure, technology and people
Quality image gallery
We set the standards that others follow
Everything we do is focused on quality, best practise and customer service and we strive to lead the industry in all three. Our quality department is fully-equipped with quality control procedures throughout the production process so we can aim for complete customer satisfaction every time.
Our employees play a vital role in ensuring quality at every stage. We're committed to developing a culture of total quality management (TQM) inside our business. And for almost a decade we've been certified to hold ISO 9001 certification for quality. We use a range of procedures and equipment to ensure quality control and continuous improvement at every stage of our work.
Independently certified for quality
We're proud to be an ISO 13485:2016 certified company. This is the industry standard for quality management systems for the medical devices industry and means we meet all appropriate ISO 9001 and FDA regulatory requirements that our customers and the regulators rightly demand.
Not every company can become certified for ISO 13485. To achieve it, we have demonstrated that we comply with a whole range of special requirements and systems:
- Risk management
- Cleanliness, sterilization and contamination management
- Customer requirements
- Clinical evaluations and trials
- Purchasing traceability and verification controls
- Requirements for implantable devices
- Proper communication of advisory notices
- Labeling and packaging controls
- Shelf-life and preservation of the product
Processes
- Statistical process control
- Complete traceability back to raw materials
- Initial sample inspection reports
- Process capability studies
- Failure mode effects analysis
Equipment
- Johansson Topaz 7 co-ordinate measuring machine with full CNC and 3D CAD interface
- OGP Smartscope Quest 300
- Faro Arm Prime
- Baty R14 Shadowmaster projector
- QI Analyst SPC programme
- Light cabinet with all standard light sources
- Full range of handheld measuring equipment
Read more about our technical expertise or to discuss your next project with a member of our team, get in touch.
ISO 9001:2015 - Quality Management System
(PDF 534 Kb) 